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Adrenaline CEP's: out of range country acceptance

1/15/2020

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CEPs are recognised by the European Pharmacopoeia member states and by a number of other countries. A full current list of the Ph. Eur. members is available on EDQM website. Based on Transo-Pharm's experience we easily penetrated those markets utilizing our CEPs for Adrenaline Base as well as Tartrate.

But what about countries outside EU or Ph. Eur. member states? 

Meanwhile we adjusted our filing strategy in this matter and our Adrenaline CEPs have been submitted to several “out of range” countries. 


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Adrenaline base and tartrate – Out of range CEP acceptance - our experience
 
After successful process implementation for both Adrenalines/Epinephrines (based on Boehringer Ingelheims homogenous enantioselective hydrogenation technology) at our toll manufacturer Syn-Tech we obtained CEP 2016-232 for our Adrenaline and CEP 2016-233 for Adrenaline tartrate. API quality and registration documentation (CMC) corresponds with USDMF #30997 and #30996.
 
Purpose and scope of a CEP is to surrogate the corresponding EDMF/ASMF as well as its individual review and assessment in each country in which the CMC is filed. As mentioned on EDQM´s homepage “Certificates of suitability (CEPs) are accepted in all EU member states and in member states of the Convention on the elaboration of a European Pharmacopoeia except Ukraine.”
 
It goes without saying that we easily penetrated these markets utilizing our CEPs. But, what is about countries outside EU or Ph. Eur. member states? EDQM mentions “Based on information received from regulatory authorities and trade associations, the following countries accept CEPs, some with conditions: Albania, Algeria, Australia, Azerbaijan, Canada, Georgia, Ghana Israel, Kyrgyzstan, Malaysia, Moldova, Morocco, New Zealand, Saudi Arabia, Singapore, South Africa, Tunisia, and Uzbekistan. CEPs are also accepted (with conditions) by the Taiwan Food and Drug Administration.”
Some of these have the European Pharmacopoeia Observer status.
 
Meanwhile we adjusted our filing strategy in this matter and our Adrenaline CEPs have been submitted to several “out of range” countries. Country list contains

  • Albania                   European Pharmacopoeia Observer
  • Algeria                    European Pharmacopoeia Observer
  • Armenia                 European Pharmacopoeia Observer
  • Australia                 European Pharmacopoeia Observer
  • Azerbaijan              European Pharmacopoeia Observer
  • Belarus                   European Pharmacopoeia Observer
  • Botswana               Out of range country
  • Brazil                       European Pharmacopoeia Observer
  • Canada                   European Pharmacopoeia Observer
  • Kenya                      Out of range country
  • Israel                       European Pharmacopoeia Observer
  • Malawi                    Out of range country
  • Malaysia                 European Pharmacopoeia Observer
  • Mauritius                Out of range country
  • Mexico                    Out of range country
  • Morocco                 European Pharmacopoeia Observer
  • New Zealand         Out of range country
  • Pakistan                 Out of range country
  • Philippines             Out of range country
  • Russia                     Out of range country
  • Saudi Arabia          Out of range country
  • Singapore              European Pharmacopoeia Observer
  • South Africa          European Pharmacopoeia Observer
  • Sudan                     Out of range country
  • Taiwan                    European Pharmacopoeia Observer
  • Tunisia                    European Pharmacopoeia Observer
  • Uganda                   Out of range country
  • Vietnam                  Out of range country
  • Zambia                   Out of range country

Some of those competent authorities asked for additional documents and/or information e. g. Attestation letter, CEP-dossier excerpt, commitment letter etc.
 
Our experience is that more and more competent authorities outside EU and Ph. Eur. membership are willing to accept our Adrenaline CEPs, some with additional information. This encourages us to further expand the “out of range country list” and to apprise you, accordingly.

cep_out_of_range_countries.pdf
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  • Home
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